Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 6 hours while symptoms last do not take more than 10 days unless directed by a doctor children under 12 years: do not use
each 15 mL contains: sodium 10 mg store between 20-25°C (68-77°F). Do not refrigerate. protect from light. Questions or comments 1-800-935-2362 (Mon-Fri 9am-5pm EST)
(In each 15 mL)
in Acetaminophen 500 mg............. Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
if skin reaction occurs, stop use and seek medical help right away.
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions or comments
1-800-935-2362 (Mon-Fri 9am-5pm EST)
citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium benzoate, sorbitol
Distributed by C.D.M.A, Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307684 | acetaminophen 500 MG in 15 mL Oral Solution | PSN | 2 |
| 307684 | acetaminophen 33.3 MG/ML Oral Solution | SCD | 2 |
| 307684 | APAP 1000 MG per 30 ML Oral Solution | SY | 2 |
| 307684 | APAP 167 MG per 5 ML Oral Solution | SY | 2 |
| 307684 | APAP 33.3 MG/ML Oral Solution | SY | 2 |
| 307684 | APAP 500 MG per 15 ML Oral Solution | SY | 2 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-809-08 | Acetaminophen | 237 mL in 1 BOTTLE | SYRUP | 237 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-809-08 | ML - Milliliter | 63868-809 | 274e8b27-06a9-42d6-ab89-9916d1f5f1c5 | 1 | 2023-08-08 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63868-809 | 63868-809-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC. | 1608b4f0-bf20-4024-b8f2-20a4df7a4b21 | 2024-12-26 | Warnings | 63868-809-08 63868-809 63868080908 14e59795-60fb-4d85-baf8-176539f86505 1608b4f0-bf20-4024-b8f2-20a4df7a4b21 |
Adverse event summaries are temporarily unavailable. Other product information remains available.